- Description The Clinical Research Assistant (CRA) assists in the daily activities of clinical research studies and clinic operations.
- This role involves working closely with clinical teams, investigators, and study participants to ensure that all required procedures and visits occur according to protocol-specific guidelines.
- Key Responsibilities: Study Familiarization: Thoroughly understand assigned studies by reading protocols, attending start-up meetings, and coordinating with the Principal Investigator and study team.
- Protocol Adherence: Ensure strict adherence to study protocols and obtain exemptions when applicable.
- Specimen Collection & Processing: Collect, process, and ship laboratory samples in accordance with study requirements.
- Patient Screening & Qualification: Collect initial psychiatric and medical information through patient interviews and access appropriate sources to qualify and accurately place patients in enrolling clinical trials.
- Study Coordination Support: Assist Clinical Research Coordinators in trial-related organization and documentation, including filing and maintaining regulatory records.
- Communication & Reporting: Communicate protocol issues to the study team, Site Administrator, Principal Investigator (PI), or Sub-Investigator as needed.
- Clinical Tasks: Perform clinical tasks such as vital signs measurement, height and weight recording, ECG administration, phlebotomy, and specimen packaging.
- Documentation & Compliance: Maintain timely source documentation and ensure compliance with sponsor-required information.
- Patient Education: Educate patients and their families about study participation and clinical drug trials in general.
- Community Engagement: Assist in community outreach events and provide appropriate community resource referrals to patients, caretakers, and family members when applicable.
- Additional Duties: Perform ad-hoc tasks and assist in other study-related activities as needed.
- Additional Responsibilities: This job description outlines the primary responsibilities of the Clinical Research Assistant; however, additional duties may be assigned as needed to support the research program or the operational needs of the organization.
- These additional responsibilities are not limited to the above and may evolve over time based on study requirements or business needs.
Requirements
Knowledge, Skills, and Abilities: Communication: Ability to communicate effectively (both written and oral) with patients, study teams, and external stakeholders. Interpersonal Skills: Excellent interpersonal and customer service skills to engage with study participants and colleagues. Organizational Skills: Strong ability to prioritize tasks, manage multiple responsibilities, and maintain documentation. Technical Proficiency: Proficiency in Microsoft Office software required; knowledge of Electronic Medical Records (EMR) systems preferred. Attention to Detail: High level of accuracy in maintaining documentation and following protocol guidelines. Team Collaboration: Ability to work independently and collaboratively within a multidisciplinary team.
